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Diagnostic Test for Ovarian Cancer Risk Before Surgery

This study is evaluating a new diagnostic test called CleoDX ovarian cancer test. This test uses five markers in the blood to help doctors better understand if an ovarian mass (a growth on the ovary) is likely to be cancerous or not, before surgery. Currently, it's only possible to know for sure after surgery. The CleoDX test has shown promise in early studies, performing better than the standard test (CA125). We are looking for women aged 18 or older who have an ovarian mass identified by imaging and are planning to have surgery. The study aims to see how well the CleoDX test works, with results expected to be analyzed by August 2026.

Study design
This is an observational study aiming to enroll 1000 women. It is designed to evaluate the effectiveness of the CleoDX ovarian cancer test.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Outcomes will be assessed during an analysis phase, which will continue for up to 12 months or until August 2026, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06566716

A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass

Recruiting
Not specifiedAges 18+Observational
Cleo Diagnostics Ltd
~1,000 participants
Updated 2025-02-04 on ClinicalTrials.gov
What's tested:CleoDX ovarian cancer test

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Calculation of the CleoDX adnexal mass score
Measured over Outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (August 2026), whichever occurs first.

Conditions

Ovarian Neoplasms

Explore related trials

Ovarian Neoplasm

Where it's being run

8 sites across 6 states
Texas3
Arizona1
Florida1
Nevada1
Tennessee1
Virginia1

Study leadership

  • Chief Scientific Officer · STUDY_DIRECTOR · Cleo Diagnostics Ltd

Who to contact

Assoc. Director of Operations Assoc. Director of Operations
[email protected]
1-855-264-4064
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

female patients =\> 18 years of age at the time of consent
Can provide written informed consent
Have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination (e.g. transvaginal ultrasound - TVU) that requires surgery, but have not yet undergone this surgery

Exclusion

Any prior confirmed diagnosis of, or treatment for, ovarian cancer
Any prior surgery resulting in removal of both ovaries
Prior history of gynecological malignancy (within last 2 years)
Prior history of melanoma (within last 2 years)
Prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy or immunotherapy
Immune-compromised. Definition: those whose weakened immune system may render them more susceptible to infection, illness, or complications. These may include patients with immune-suppressive conditions (e.g. HIV/AIDS), patients undergoing immuno-, chemo- or radio-therapy (within the last 12 months) for any reason, receiving immune suppressive therapies (e.g. transplant recipients, individuals with known autoimmune disease), or with a primary immunodeficiency disorder (e.g. Lupus).
Pregnant currently or within the last 3 months based on participant self-report

What this trial measures

  • Calculation of the CleoDX adnexal mass scoreOutcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (August 2026), whichever occurs first.

    Determine the Cleo Diagnostics (CleoDX) adnexal mass score in patients identified with an adnexal mass requiring surgery, but who have not yet undergone this surgery.